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Pharmacokinetics, Safety and Pharmacodynamics After Multiple Oral Doses of Dabigatran Etexilate Capsule in Healthy Japanese and Caucasian Male Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02171468
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : June 24, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To investigate and compare pharmacokinetics, safety and pharmacodynamics of dabigatran etexilate following oral administration of multiple doses (110 mg and 150 mg b.i.d., 7 days) in healthy male subjects between Japanese and Caucasians

Condition or disease Intervention/treatment Phase
Healthy Drug: Dabigatran high dose Drug: Dabigatran low dose Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics, Safety and Pharmacodynamics After Multiple Oral Doses of Dabigatran Etexilate Capsule (110 mg and 150 mg b.i.d., 7 Days) in Healthy Japanese and Caucasian Male Subjects (Open Label Study)
Study Start Date : May 2006
Actual Primary Completion Date : July 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dabigatran high dose Drug: Dabigatran high dose
Experimental: Dabigatran low dose Drug: Dabigatran low dose

Primary Outcome Measures :
  1. Occurrence of adverse events [ Time Frame: up to 10 days ]
  2. Changes in QT(c) intervals [ Time Frame: up to 7 days ]
  3. Cmax,ss (maximum measured concentration of the analyte in plasma at steady state) [ Time Frame: up to 7 days ]
  4. AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) [ Time Frame: up to 7 days ]

Secondary Outcome Measures :
  1. Cmax (maximum measured concentration) [ Time Frame: day 1 ]
  2. tmax (time from dosing to maximum measured concentration) [ Time Frame: day 1 ]
  3. AUCτ,1 (area under the concentration-time curve over a uniform dosing interval τ after administration of single dose on Day 1) [ Time Frame: day 1 ]
  4. tmax,ss (time from last dosing to maximum concentration at steady state) [ Time Frame: up to 7 days ]
  5. Cmin,ss (minimum concentration at steady state over a uniform dosing interval τ) [ Time Frame: up to 7 days ]
  6. λz,ss (terminal rate constant at steady state) [ Time Frame: up to 7 days ]
  7. t1/2,ss (terminal half-life at steady state) [ Time Frame: up to 7 days ]
  8. MRTpo,ss (mean residence time in the body at steady state after oral administration) [ Time Frame: up to 7 days ]
  9. CL/F,ss (apparent clearance in the plasma at steady state after extravascular multiple dose administration) [ Time Frame: up to 7 days ]
  10. Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration) [ Time Frame: up to 7 days ]
  11. RA,Cmax,13 (accumulation ratio calculated as Cmax,ss/Cmax) [ Time Frame: up to 7 days ]
  12. RA,AUC,13 (accumulation ratio calculated as AUCτ,ss/AUCτ,1) [ Time Frame: up to 7 days ]
  13. area under the curve for activated partial thromboplastin time (aPTT) [ Time Frame: 0 - 12 hours after adminstration on day 1 and day 7 ]
  14. area under the curve for ecarin clotting time (ECT) [ Time Frame: 0 - 12 hours after adminstration on day 1 and day 7 ]
  15. comparison of trough concentrations [ Time Frame: after doses 3, 5, 7, 9, 11 and 13 ]
  16. comparison of trough concentrations morning versus evening [ Time Frame: after doses 9, 10, 11, 12, 13 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Japanese or Caucasian healthy male subjects according to the following criteria:

    Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate and body temperature), 12-lead electrocardiogram, clinical laboratory tests

    • No finding of clinical relevance
    • No evidence of a clinically relevant concomitant disease
    • Caucasian subjects are from a well-defined Caucasian population, both parents of Caucasians, the subjects can understand the subject information for informed consent in English and the subjects have lived 8 or less than 8 years in Japan
  2. Age: ≥20 and ≤45 years
  3. Body mass index (BMI): ≥18.5 and ≤29.9 kg/m2
  4. Signed and dated written informed consent before admission to the trial site

Exclusion Criteria:

  1. Current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  2. Subject can not use an adequate form of contraception from the time of the first dose on Day 1 up to end-of study examination
  3. Current diseases of the central nervous system (such as epilepsy), or psychiatric disorders or neurological disorders
  4. History of clinically significant orthostatic hypotension, clinically significant current or past fainting spells or blackouts
  5. Chronic or relevant acute infections
  6. History of

    • allergy/hypersensitivity (including drug allergy) which is deemed relevant to the safety assessment as judged by the investigator (excluding asymptomatic seasonal rhinitis/hay fever)
    • any bleeding disorder including prolonged or habitual bleeding
    • other hematologic diseases
    • cerebral bleeding (e.g. after a car accident)
    • concussions (head trauma resulting in injuring to brain) with or without loss of consciousness
  7. Intake of drugs with a long half-life (>24 hours) within at least 1 month or less than 10 half-lives, whichever is shorter, of the respective drug prior to administration or during the trial
  8. Use of aspirin (including over-the-counter medications), antipletelet agents like ticlopidine or dipyridamole, chronic administration of nonsteroidal antiinflammatory drugs , coumadin like anticoagulants, chronic use of corticosteroids, heparin or fibrinolytic agents within 28 days prior to administration up to end-of-study examination
  9. Participation in another trial with an investigational drug within 3 months prior to administration up to end-of-study examination
  10. Smoker (>10 cigarettes/day or inability to refrain from smoking during the trial)
  11. Alcohol abuse (more than 60 g/day; confirmed by interview)
  12. Drug abuse (confirmed by interview)
  13. Blood donation (more than 100 mL from 3 months prior to screening and any blood donation from screening up to end-of-study examination)
  14. Excessive physical activities (within 7 days prior to the first drug administration up to end-of-study examination)
  15. Any laboratory value outside the reference range that is of clinical relevance
  16. Known hypersensitivity to the investigational drug or its excipients
  17. Subject who was judged ineligible by the investigator or the sub-investigator
  18. History of any familial bleeding disorder
  19. Thrombocytes <15 x 10**4 /microL

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Responsible Party: Boehringer Ingelheim Identifier: NCT02171468     History of Changes
Other Study ID Numbers: 1160.61
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action